FDA.reportPublic FDA data

Baclofen

Product NDC
0615-8518
11-digit product format
006158518
Labeler code
0615
Product ID
0615-8518_8c1dfdbe-e30f-436d-882e-8b4c5f8ca29a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Baclofen
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA215885
Marketing category
ANDA
Marketing start
2022-01-26
Substance
BACLOFEN
Active strength
5 mg/1
Pharmacologic classes
GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Baclofen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACLOFEN5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH789N3FKE8
Rxcui430902

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
1e25d01b-2e92-4765-bec7-8a0fd7bdc346Product name220251208
1b1393e5-f2d8-42f5-a070-e3416d619667Product name120250804
88583480-702d-4dfe-a31c-9c00abd818f8Product name720250729
1cf3c538-592e-4b4b-869e-51d4bf3ca83dProduct name220240703
6e532d1f-e0b5-46eb-a2be-d70bd338df9dProduct name120220613
ef6bc0bf-8134-f06b-70d9-4980df6f808eProduct name520210615
eeec0918-7a2f-44bf-83d6-1216e507adbfProduct name320191217
a5300adb-f538-4abb-a49e-f8f0b8d9ac75Product name120190611

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8518-05Baclofen15 in 1 BLISTER PACKTABLET152
0615-8518-39Baclofen30 in 1 BLISTER PACKTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8518BACLOFEN TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]2Current NDC, 2 package rows20241006_ea4ad5c5-207c-4a68-8e6e-4ff101777e5c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
430902baclofen 5 MG Oral TabletPSNea4ad5c5-207c-4a68-8e6e-4ff101777e5c2
430902baclofen 5 MG Oral TabletSCDea4ad5c5-207c-4a68-8e6e-4ff101777e5c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0615-8518-050061585180515 TABLET in 1 BLISTER PACK (0615-8518-05) 15 tablet2024-08-14NoNoCurrent
0615-8518-390061585183930 TABLET in 1 BLISTER PACK (0615-8518-39) 30 tablet2024-08-14NoNoCurrent